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EFFORT: The Effect of Dietary Fat Content on the Recurrence of Pancreatitis

Sponsor
University of Pecs (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04761523
Collaborator
(none)
384
Enrollment
2
Arms
52
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dietary intervention: reduced fat diet
  • Behavioral: Dietary intervention: standard healthy diet
 N/A

Detailed Description

Around 20% of patients with acute pancreatitis (AP) will go on to have acute recurrent pancreatitis (ARP) and 10% progress to chronic pancreatitis (CP). While interventions to avoid recurrences exist for the two most common causes - removal of the cholecyst in the case of biliary, and alcohol seccation in the case of alcoholic - a method to prevent idiopathic pancreatitis is not yet known. Although none of the guidelines suggest the administration of low fat diet, it is recommended by physicians to all pancreatitis patients are. Our aim is to conduct a randomized controlled trial, to assess the problem of dietary fat reduction on the recurrence of acute pancreatitis Patients, who had at least two acute pancreatitis episodes in the preceding 2 year will be approached to participate in the study and to either to be randomized to the 'reduced fat diet' (15% fat, 65% carbohydrate, 20% protein) or to the 'standard healthy diet' (30% fat, 50% carbohydrate, 20% protein; based on WHO recommendations) group. During the 2 year long followup, participants will receive repeated dietary intervention at 3, 6, 12, 18, 24 months, they will completer food frequency questionnaires and their data regarding mortality, BMI, cardiovascular parameters and serum lipid values will be recorded The EFFORT trial will determine the effect of modified dietary fat content on the recurrence of AP, mortality, serum lipids and weight loss in idiopathic cases.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
384 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Masking Description:
Doctors caring for the participants and assessors of all other outcomes (laboratory parameters, BMI, blood pressure, adverse events) as well as statisticians handling the data will be blinded to the participants' allocated group. Outcome assessors will be not avare of the allocated interventions.
Primary Purpose:
Prevention
Official Title:
The Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT): Protocol of a Multicentre Randomized Controlled Trial
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Reduced fat arm

Daily calorie intake will be composed of 15% fat, 65% carbohydrates, 20% proteins

Behavioral: Dietary intervention: reduced fat diet
Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 15% fat, 65% carbohydrate, 20% protein content.
Active Comparator: Standard healthy diet arm

Daily calorie intake will be composed of 30% fat, 50% carbohydrates and 20% proteins.

Behavioral: Dietary intervention: standard healthy diet
Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content.

Outcome Measures

Primary Outcome Measures

  1. Occurrence of recurrent acute pancreatitis and/or all-cause mortality [Data will be recorded during the 3-6-12-18-24 months followup visits]

    The recurrence of acute pancreatitis (given as a rate of event) AND/OR all-cause mortality.

Secondary Outcome Measures

  1. Proportion of pancreas specific mortality [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Mortality of a pancreatic cause

  2. Proportion of cardiosvascular cause mortality [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Mortality of a cardiovascular cause.

  3. Proportion of newly diagnosed chronic pancreatitis patients [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Newly diagnosed chronic pancreatitis.

  4. Changes in BMI [Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits]

    Changes in BMI compared to baseline both in total and percentage

  5. Serum total cholesterol [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Serum total cholesterol absolute value

  6. Change in serum total cholesterol [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Serum total cholesterol compared to baseline

  7. Serum triglyceride [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Serum triglyceride absolute value

  8. Change in serum triglyceride [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Serum triglyceride compared to baseline

  9. Serum high density liporpotein(HDL)-cholesterol [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Serum high density liporpotein(HDL)-cholesterol absolute value

  10. Change in serum high density liporpotein(HDL)-cholesterol [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Serum high density liporpotein(HDL)-cholesterol compared to baseline

  11. Serum low density liporpotein(LDL)-cholesterol [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Serum low density liporpotein(LDL)-cholesterol absolute value

  12. Change in serum low density liporpotein(LDL)-cholesterol [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Serum low density liporpotein(LDL)-cholesterol compared to baseline

  13. Systolic blood pressure value [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Systolic blood pressure absolute value

  14. Change in systolic blood pressure [Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits]

    Systolic blood pressure compared to baseline

  15. Diastolic blood pressure [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Diastolic blood pressure absolute value

  16. Change in siastolic blood pressure [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Diastolic blood pressure compared to baseline

  17. Adherence to dietary recommendations as determined by the result of the food frequency questionnaire [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Adherence to dietary recommendations as determined by the result of the food frequency questionnaire

  18. Adverse effects [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Adverse effects given as rate of events

  19. Serum albumin value [Data will be recorded during the 3-6-12-18-24 months followup visits]

    Serum albumin absolute value

  20. Change in serum albumin value [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Serum albumin value compared to baseline

  21. Proportion of current smokers [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Current smoking at each visit

  22. Quality of life questionnaire on mobility, self-care, usual activities, pain/discomfort and anxiety/depression [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Quality of life assessed by the EQ-5D-5L questionnaire

  23. Muscle strength [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Muscle strength using a handgrip dynamometer

  24. Vitamin A value [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Vitamin A absolute value

  25. Change in vitamin A value [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Change in vitamin A value compared to baseline

  26. Vitamin D value [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Vitamin D absolute value

  27. Change in vitamin D value [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Change in vitamin D value compared to baseline

  28. Vitamin E value [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Vitamin E absolute value

  29. Change in vitamin E value [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Change in vitamin E value compared to baseline

  30. Vitamin K value [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Vitamin K absolute value

  31. Change in vitamin K value [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Change in vitamin K value compared to baseline

  32. Change in smoking [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Change in smoking compared to baseline

  33. Change in quality of life [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Change in quality of life assessed by the EQ-5D-5L questionnaire compared to baseline

  34. Change in muscle strength [Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

    Change in muscle strength using a handgrip dynamometer compared to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Individuals with at least two episodes of acute pancreatitis in the 2 years preceding the inclusion with

  • The last episode being idiopathic, who are

  • Older than 14 years.

Exclusion Criteria:

  • Individuals already receiving regular nutritional guidance (with medical indication),

  • Individuals in critical condition or in terminal stage of cancer (with an expected survival <2 years) ,

  • Individuals undergoing treatment for active malignancy,

  • Individuals with uncontrolled diabetes mellitus (admitted lack of compliance with antidiabetic therapy / HbA1c >6.5% / indication of uncontrolled diabetes mellitus in last 24 months' anamnesis / newly discovered diabetes mellitus)

  • Individuals with known cholecystolithiasis

  • Individuals who are pregnant or nursing

  • Individuals with a BMI < 18.5

  • Individuals who are regularly receiving systemic corticosteroids

  • Individuals consuming more alcohol than: 5 units per day or 15 units per week for men; 4 units per day or 8 units per week for women.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Pecs

Investigators

  • Study Chair: Péter Hegyi, MD, PhD, DSc, Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Dr Hegyi Péter, Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs, University of Pecs
ClinicalTrials.gov Identifier:
NCT04761523
Other Study ID Numbers:
  • 40304-11/2020/EÜIG
First Posted:
Feb 21, 2021
Last Update Posted:
Feb 15, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Hegyi Péter, Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs, University of Pecs
acute pancreatitis
dietary fat
low-fat diet
pancreatitis recurrence
Additional relevant MeSH terms:
Pancreatitis
Recurrence

Study Results

No Results Posted as of Feb 15, 2022